IN THE SENATE OF THE UNITED STATES
February 15, 2007
Mr. Durbin (for himself and Mr. Schumer) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry
To establish the Food Safety Administration to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.
Short title; table of contents
This Act may be cited as the
Safe Food Act of 2007.
Table of contents
The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings; purposes.
Sec. 3. Definitions.
TITLE I—Establishment of Food Safety Administration
Sec. 101. Establishment of Food Safety Administration.
Sec. 102. Consolidation of separate food safety and inspection services and agencies.
Sec. 103. Additional duties of the Administration.
TITLE II—Administration of food safety program
Sec. 201. Administration of national program.
Sec. 202. Registration of food establishments and foreign food establishments.
Sec. 203. Preventative process controls to reduce adulteration of food.
Sec. 204. Performance standards for contaminants in food.
Sec. 205. Inspections of food establishments.
Sec. 206. Food production facilities.
Sec. 207. Federal and State cooperation.
Sec. 208. Imports.
Sec. 209. Resource plan.
Sec. 210. Traceback.
TITLE III—Research and education
Sec. 301. Public health assessment system.
Sec. 302. Public education and advisory system.
Sec. 303. Research.
Sec. 401. Prohibited Acts.
Sec. 402. Food detention, seizure, and condemnation.
Sec. 403. Notification and recall.
Sec. 404. Injunction proceedings.
Sec. 405. Civil and criminal penalties.
Sec. 406. Presumption.
Sec. 407. Whistleblower protection.
Sec. 408. Administration and enforcement.
Sec. 409. Citizen civil actions.
Sec. 501. Definition.
Sec. 502. Reorganization plan.
Sec. 503. Transitional authorities.
Sec. 504. Savings provisions.
Sec. 505. Conforming amendments.
Sec. 506. Additional technical and conforming amendments.
Sec. 507. Regulations.
Sec. 508. Authorization of appropriations.
Sec. 509. Limitation on authorization of appropriations.
Sec. 510. Effective date.
Congress finds that—
the safety of the food supply of the United States is vital to the public health, to public confidence in the food supply, and to the success of the food sector of the Nation's economy;
lapses in the protection of the food supply and loss of public confidence in food safety are damaging to consumers and the food industry, and place a burden on interstate commerce;
the safety and security of the food supply requires an integrated, system-wide approach to preventing food-borne illness, a thorough and broad-based approach to basic and applied research, and intensive, effective, and efficient management of the Nation's food safety program;
the task of preserving the safety of the food supply of the United States faces tremendous pressures with regard to—
emerging pathogens and other contaminants and the ability to detect all forms of contamination;
an aging and immune compromised population, with a growing number of people at high-risk for food-borne illnesses, including infants and children;
an increasing volume of imported food, without adequate monitoring and inspection; and
maintenance of rigorous inspection of the domestic food processing and food service industries;
Federal food safety standard setting, inspection, enforcement, and research efforts should be based on the best available science and public health considerations and food safety resources should be systematically deployed in ways that most effectively prevent food-borne illness;
the Federal food safety system is fragmented, with at least 12 Federal agencies sharing responsibility for food safety, and operates under laws that do not reflect current conditions in the food system or current scientific knowledge about the cause and prevention of food-borne illness;
the fragmented Federal food safety system and outdated laws preclude an integrated, system-wide approach to preventing food-borne illness, to the effective and efficient operation of the Nation's food safety program, and to the most beneficial deployment of food safety resources;
Academy of Sciences recommended in the report
Ensuring Safe Food from
Production to Consumption that Congress establish by statute a unified
and central framework for managing Federal food safety programs, and
recommended modifying Federal statutes so that inspection, enforcement, and
research efforts are based on scientifically supportable assessments of risks
to public health; and
the lack of a single focal point for food safety leadership in the United States undercuts the ability of the United States to exert food safety leadership internationally, which is detrimental to the public health and the international trade interests of the United States.
The purposes of this Act are—
to establish a
single agency to be known as the
Food Safety Administration
regulate food safety and labeling to strengthen the protection of the public health;
ensure that food establishments fulfill their responsibility to produce food in a manner that protects the public health of all people in the United States;
lead an integrated, system-wide approach to food safety and to make more effective and efficient use of resources to prevent food-borne illness;
provide a single focal point for food safety leadership, both nationally and internationally; and
provide an integrated food safety research capability, utilizing internally-generated, scientifically and statistically valid studies, in cooperation with academic institutions and other scientific entities of the Federal and State governments, to achieve the continuous improvement of research on food-borne illness and contaminants;
to transfer to the Food Safety Administration the food safety, labeling, inspection, and enforcement functions that, as of the day before the effective date of this Act, are performed by other Federal agencies; and
to modernize and strengthen the Federal food safety laws to achieve more effective application and efficient management of the laws for the protection and improvement of public health.
In this Act:
The term Administration means the Food Safety Administration established under section 101(a)(1).
The term Administrator means the Administrator of Food Safety appointed under section 101(a)(3).
The term adulterated has the meaning described in subsections (a) through (c) of section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).
The term adulterated includes bearing or containing a contaminant that causes illness or death among sensitive populations.
agency has the meaning given that term in section 551 of
title 5, United States Code.
Category 1 food establishment
The term category 1 food establishment means a food establishment that slaughters animals for food.
Category 2 food establishment
The term category 2 food establishment means a food establishment that processes raw meat, poultry, seafood products, regardless of whether the establishment also has a kill step, and animal feed and other products that the Administrator determines by regulation to be at high risk of contamination and the processes of which do not include a step validated to destroy contaminants.
Category 3 food establishment
The term category 3 food establishment means a food establishment that processes meat, poultry, seafood products, and other products that the Administrator determines by regulation to be at high risk of contamination and whose processes include a step validated to destroy contaminants.
Category 4 food establishment
The term category 4 food establishment means a food establishment that processes all other categories of food products not described in paragraphs (5) through (7).
Category 5 food establishment
The term category 5 food establishment means a food establishment that stores, holds, or transports food products prior to delivery for retail sale.
The term contaminant includes a bacterium, chemical, natural or manufactured toxin, virus, parasite, prion, physical hazard, or other human pathogen that when found on or in food can cause human illness, injury, or death.
The term contamination refers to a presence of a contaminant in food.
The term food means a product intended to be used for food or drink for a human or an animal.
The term food includes any product (including a meat food product, as defined in section 1(j) of the Federal Meat Inspection Act (21 U.S.C. 601(j))), capable for use as human food that is made in whole or in part from any animal, including cattle, sheep, swine, or goat, or poultry (as defined in section 4 of the Poultry Products Inspection Act (21 U.S.C. 453)), and animal feed.
The term food does not include dietary supplements, as defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)).
The term food establishment means a slaughterhouse, factory, warehouse, or facility owned or operated by a person located in any State that processes food or a facility that holds, stores, or transports food or food ingredients.
For the purposes of registration, the term food establishment does not include a farm, restaurant, other retail food establishment, nonprofit food establishment in which food is prepared for or served directly to the consumer, or fishing vessel (other than a fishing vessel engaged in processing, as that term is defined in section 123.3 of title 21, Code of Federal Regulations).
Food production facility
The term food production facility means any farm, ranch, orchard, vineyard, aquaculture facility, or confined animal-feeding operation.
Food safety law
The term food safety law means—
the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) related to and requiring the safety, labeling, and inspection of food, infant formulas, food additives, pesticide residues, and other substances present in food under that Act;
the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and of any other Act that are administered by the Center for Veterinary Medicine of the Food and Drug Administration;
the Poultry Products Inspection Act (21 U.S.C. 451 et seq.);
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);
the Sanitary Food Transportation Act of 1990 (49 U.S.C. App. 2801 et seq.);
the amendments made by the Sanitary Food Transportation Act of 2005 (subtitle B of title VII of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users) (21 U.S.C. 301 note);
the provisions of the Humane Methods of Slaughter Act of 1978 (21 U.S.C. 601 note) administered by the Food Safety and Inspection Service;
the provisions of this Act; and
such other provisions of law related to and requiring food safety, labeling, inspection, and enforcement as the President designates by Executive order as appropriate to include within the jurisdiction of the Administration.
Foreign food establishment
The term foreign food establishment means a slaughterhouse, factory, warehouse, or facility located outside the United States that processes food for consumption that is imported into the United States or food ingredients.
The term interstate commerce has the meaning given that term in section 201(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(b)).
The term misbranded has the meaning given that term in section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343).
The term process or processing means the commercial harvesting, slaughter, packing, preparation, or manufacture of food.
The term safe refers to human and animal health.
The term State means—
the District of Columbia;
the Commonwealth of Puerto Rico; and
any other territory or possession of the United States.
The term validation means the obtaining of evidence that the food hygiene control measure or measures selected to control a hazard in food is capable of effectively and consistently controlling the hazard.
With respect to a study, the term statistically valid means evaluated and conducted under standards set by the National Institute of Standards and Technology.
Establishment of Food Safety Administration
Establishment of Food Safety Administration
There is established in the executive branch an agency to
be known as the
Food Safety Administration.
The Administration shall be an independent establishment (as defined in section 104 of title 5, United States Code).
Head of administration
The Administration shall be headed by the Administrator of Food Safety, who shall be appointed by the President, by and with the advice and consent of the Senate.
Duties of Administrator
The Administrator shall—
administer and enforce the food safety law;
serve as a representative to international food safety bodies and discussions;
promulgate regulations to ensure the security of the food supply from all forms of contamination, including intentional contamination; and
implementation of Federal food safety inspection, enforcement, and research efforts, to protect the public health;
development of consistent and science-based standards for safe food;
coordination and prioritization of food safety research and education programs with other Federal agencies;
prioritization of Federal food safety efforts and deployment of Federal food safety resources to achieve the greatest possible benefit in reducing food-borne illness;
coordination of the Federal response to food-borne illness outbreaks with other Federal and State agencies; and
integration of Federal food safety activities with State and local agencies.
Consolidation of separate food safety and inspection services and agencies
Transfer of functions
For each Federal agency specified in subsection (b), there are transferred to the Administration all functions that the head of the Federal agency exercised on the day before the effective date of this Act (including all related functions of any officer or employee of the Federal agency) that relate to administration or enforcement of the food safety law, as determined by the President.
The Federal agencies referred to in subsection (a) are—
the Food Safety and Inspection Service of the Department of Agriculture;
the Center for Food Safety and Applied Nutrition of the Food and Drug Administration;
the part of the Agriculture Marketing Service that administers shell egg surveillance services established under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);
the resources and facilities of the Office of Regulatory Affairs of the Food and Drug Administration that administer and conduct inspections of food establishments and imports;
the resources and facilities of the Office of the Commissioner of the Food and Drug Administration that support—
the Center for Food Safety and Applied Nutrition;
the Center for Veterinary Medicine; and
the Office of Regulatory Affairs facilities and resources described in paragraph (4);
the Center for Veterinary Medicine of the Food and Drug Administration;
the resources and facilities of the Environmental Protection Agency that control and regulate pesticide residues in food;
the part of the Research, Education, and Economics mission area of the Department of Agriculture related to food safety and animal feed research;
the part of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration of the Department of Commerce that administers the seafood inspection program;
the Animal and Plant Inspection Health Service of the Department of Agriculture; and
such other offices, services, or agencies as the President designates by Executive order to carry out this Act.
Additional duties of the Administration
Officers and employees
The Administrator may—
appoint officers and employees for the Administration in accordance with the provisions of title 5, United States Code, relating to appointment in the competitive service; and
fix the compensation of those officers and employees in accordance with chapter 51 and with subchapter III of chapter 53 of that title, relating to classification and General Schedule pay rates.
Experts and consultants
The Administrator may—
procure the services of temporary or intermittent experts and consultants as authorized by section 3109 of title 5, United States Code; and
pay in connection with those services the travel expenses of the experts and consultants, including transportation and per diem in lieu of subsistence while away from the homes or regular places of business of the individuals, as authorized by section 5703 of that title.
Bureaus, offices, and divisions
The Administrator may establish within the Administration such bureaus, offices, and divisions as the Administrator determines are necessary to perform the duties of the Administrator.
The Administrator shall establish advisory committees that consist of representatives of scientific expert bodies, academics, industry specialists, and consumers.
The duties of an advisory committee established under paragraph (1) may include developing recommendations with respect to the development of new processes, research, communications, performance standards, and inspection.
Administration of food safety program
Administration of national program
The Administrator shall—
national food safety program (referred to in this section as the
program) to protect public health; and
ensure that persons who produce or process food meet their responsibility to prevent or minimize food safety hazards related to their products.
The program shall be based on a comprehensive analysis of the hazards associated with different food and with the processing of different food, including the identification and evaluation of—
the severity of the potential health risks;
the sources and specific points of potential contamination extending from the farm or ranch to the consumer that may render food unsafe;
the potential for persistence, multiplication, or concentration of naturally occurring or added contaminants in food;
opportunities across the food production, processing, distribution, and retail system to reduce potential health risks; and
opportunities for intentional contamination.
In carrying out the program, the Administrator shall—
adopt and implement a national system for the registration of food establishments and foreign food establishments and regular unannounced inspection of food establishments;
enforce the adoption of process controls in food establishments, based on best available scientific and public health considerations and best available technologies;
establish and enforce science-based standards for—
substances that may contaminate food; and
safety and sanitation in the processing and handling of food;
implement a statistically valid sampling program to ensure that industry programs and procedures that prevent food contamination are effective on an ongoing basis and that food meets the standards established under this Act;
implement procedures and requirements to ensure the safety and security of imported food;
coordinate with other agencies and State or local governments in carrying out inspection, enforcement, research, and monitoring;
have access to the surveillance data of the Centers for Disease Control and Prevention, and other Federal Government agencies, in order to implement a national surveillance system to assess the health risks associated with the human consumption of food or to create surveillance data and studies;
develop public education risk communication and advisory programs;
implement a basic and applied research program to further the purposes of this Act; and
coordinate and prioritize food safety research and educational programs with other agencies, including State or local agencies.
Registration of food establishments and foreign food establishments
The Administrator shall by regulation require that any food establishment or foreign food establishment engaged in processing food in the United States be registered with the Administrator.
To be registered under subsection (a)—
in the case of a food establishment, the owner, operator, or agent in charge of the food establishment shall submit a registration to the Administrator; and
in the case of a foreign food establishment, the owner, operator, or agent in charge of the foreign food establishment shall—
submit a registration to the Administrator; and
provide the name, address, and emergency contact information of the United States agent for the foreign food establishment.
A food establishment or foreign food establishment shall submit a registration under paragraph (1) to the Administrator that—
identifies the name, address, and emergency contact information of each food establishment or foreign food establishment that the registrant operates under this Act and all trade names under which the registrant conducts business relating to food;
lists the primary purpose and business activity of each food establishment or foreign food establishment, including the dates of operation if the food establishment or foreign food establishment is seasonal;
lists the types of food processed or sold at each food establishment or, for foreign food establishments selling food for consumption in the United States, identifies the specific food categories of that food as listed under section 170.3 of title 21, Code of Federal Regulations; and
not later than 30 days after a change in the products, function, or legal status of the food establishment or foreign food establishment (including cessation of business activities), notifies the Administrator of the change.
Upon receipt of a completed registration described in paragraph (1), the Administrator shall notify the registrant of the receipt of the registration, designate each establishment as a category 1, 2, 3, 4, or 5 food establishment, and assign a registration number to each food establishment and foreign food establishment.
The Administrator shall compile and maintain an up-to-date list of food establishments and foreign food establishments that are registered under this section. The Administrator may establish regulations by which such list may be shared with other governmental authorities.
The disclosure requirements under section 552 of title 5, United States Code, shall not apply to—
the list compiled under paragraph (4); and
information derived from the list under paragraph (4), to the extent that it discloses the identity or location of a specific registered person.
Suspension of registration
The Administrator may suspend the registration of a food establishment or foreign food establishment, including the facility of an importer, for violation of a food safety law.
Notice and opportunity for hearing
The Administrator shall provide notice to a registrant immediately upon the suspension of the registration of the facility and provide registrant with an opportunity for a hearing within 3 days of the suspension.
A registration that is suspended under this section may be reinstated pursuant to criteria published in the Federal Register by the Administrator.
Preventative process controls to reduce adulteration of food
The Administrator shall, upon the basis of best available public health, scientific, and technological data, promulgate regulations to ensure that food establishments carry out their responsibilities to—
process food in a sanitary manner so that it is free of dirt and filth;
limit the presence of potentially harmful contaminants in food;
implement appropriate measures of preventative process control to minimize and reduce the presence and growth of contaminants in food and meet the performance standards established under section 204;
process all fully processed or ready-to-eat food in a sanitary manner, using reasonably available techniques and technologies to eliminate any potentially harmful contaminants; and
label food intended for final processing outside commercial food establishments with instructions for handling and preparation for consumption that will destroy contaminants.
Not later than 1 year after the effective date of this Act, the Administrator shall promulgate regulations that—
require all food establishments to adopt preventative process controls that are—
adequate to protect the public health;
meet relevant regulatory and food safety standards; and
limit the presence and growth of contaminants in food prepared in a food establishment;
set standards for sanitation;
meet any performance standards for contaminants established under section 204;
require recordkeeping to monitor compliance;
require sampling and testing at a frequency and in a manner sufficient to ensure that process controls are effective on an ongoing basis and that regulatory standards are being met; and
provide for agency access to records kept by food establishments and submission of copies of the records to the Administrator, as the Administrator determines appropriate.
The Administrator may require any person with responsibility for or control over food or food ingredients to adopt process controls, if the process controls are needed to ensure the protection of the public health.
Performance standards for contaminants in food
To protect the public health, the Administrator shall establish by regulation and enforce performance standards that define, with respect to specific food-borne contaminants and foods, the level of food safety performance that a person responsible for producing, processing, or selling food shall meet.
Identification of contaminants; performance standards
Not later than 6 months after the date of enactment of this Act, the Administrator shall identify the food-borne contaminants and food that contribute significantly to the risk of food-borne illness.
As soon as practicable after the identification of the contaminants under paragraph (1), the Administrator shall establish appropriate performance standards to protect against all food-borne contaminants.
The Administrator shall establish performance standards for the 5 contaminants that contribute to the greatest number of illnesses or deaths associated with raw meat, poultry, and seafood not later than 3 years after the date of enactment of this Act. The Administrator shall revise such standards not less often than every 3 years.
The performance standards established under this section shall include—
health-based standards that set the level of a contaminant that can safely and lawfully be present in food;
zero tolerances, including zero tolerances for fecal matter, in addition to any zero-tolerance standards in effect on the day before the date of enactment of this Act, when necessary to protect against significant adverse health outcomes;
process standards, such as log reduction criteria for cooked products, when sufficient to ensure the safety of processed food; and
in the absence of data to support a performance standard described in subparagraph (A), (B), or (C), standards that define required performance in terms of “best reasonably achievable performance”, using best available technologies, interventions, and practices.
Best reasonably achievable performance standards
In developing best reasonably achievable performance standards, the Administrator shall collect, or contract for the collection of, data on current best practices and food safety outcomes related to the contaminants and foods in question, as the Administrator determines necessary.
Revocation by administrator
All performance standards, tolerances, action levels, or other similar standards in effect on the date of enactment of this Act shall remain in effect until revised or revoked by the Administrator.
Not later than 1 year after the promulgation of a performance standard under this section, the Administrator shall implement a statistically significant sampling program to determine whether food establishments are complying with the performance standards promulgated under this section. The program established under this paragraph shall be at least as stringent as the Hazard Analysis and Critical Control Point System requirements established under part 417 of title 9, Code of Federal Regulations (or successor regulation).
If the Administrator determines that a food establishment fails to meet a standard promulgated under this section, and such establishment fails to take appropriate corrective action as determined by the Administrator, the Administrator shall, as appropriate—
detain, seize, or condemn food from the food establishment under section 402;
order a recall of food from the food establishment under section 403;
increase the inspection frequency for the food establishment;
withdraw the mark of inspection from the food establishment, if in use; or
take other appropriate enforcement action concerning the food establishment, including withdrawal of registration.
Newly Identified contaminants
Notwithstanding any other provision of this section, the Administrator shall promulgate interim performance standards for newly identified contaminants as necessary to protect the public health.
Inspections of food establishments
The Administrator shall establish an inspection program, which shall include sampling and testing of food and food establishments, to determine if each food establishment—
is operating in a sanitary manner;
has continuous systems, interventions, and processes in place to minimize or eliminate contaminants in food;
is in compliance with applicable performance standards established under section 204, and other regulatory requirements;
is processing food that is safe and not adulterated or misbranded;
maintains records of process control plans under section 203, and other records related to the processing, sampling, and handling of food; and
is in compliance with the requirements of the food safety law.
Establishment categories and inspection frequencies
The resource plan required under section 209, including the description of resources required to carry out inspections of food establishments, shall be based on the following categories and inspection frequencies, subject to subsections (c), (d), and (e):
Category 1 food establishments
A category 1 food establishment shall be subject to antemortem, postmortem, and continuous inspection of each slaughter line during all operating hours, and other inspection on a daily basis, sufficient to verify that—
diseased animals are not offered for slaughter;
the food establishment has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses, has avoided cross-contamination, and destroyed or reprocessed them in a manner acceptable to the Administrator; and
that applicable performance standards and other provisions of the food safety law, including those intended to eliminate or reduce pathogens, have been satisfied.
Category 2 food establishments
A category 2 food establishment shall be randomly inspected at least daily.
Category 3 food establishments
A category 3 food establishment shall—
have ongoing verification that its processes are controlled; and
be randomly inspected at least monthly.
Category 4 food establishments
A category 4 food establishment shall be randomly inspected at least quarterly.
Category 5 food establishments
A category 5 food establishment shall be randomly inspected at least annually.
Establishment of inspection procedures
The Administrator shall establish procedures under which inspectors or safety officers shall take random samples, photographs, and copies of records in food establishments.
Alternative inspection frequencies
With respect to a category 2, 3, 4, or 5 food establishment, the Administrator may establish alternative increasing or decreasing inspection frequencies for subcategories of food establishments or individual establishments, to foster risk-based allocation of resources, subject to the following criteria and procedures:
Subcategories of food establishments and their alternative inspection frequencies shall be defined by regulation, subject to paragraphs (2) and (3).
Regulations of alternative inspection frequencies for subcategories of food establishments under paragraph (1) and for a specific food establishment under paragraph (4) shall provide that—
category 2 food establishments shall be inspected at least monthly; and
category 3, 4, and 5 food establishments shall be inspected at least annually.
In defining subcategories of food establishments and their alternative inspection frequencies under paragraphs (1) and (2), the Administrator shall consider—
the nature of the food products being processed, stored, or transported;
the manner in which food products are processed, stored, or transported;
the inherent likelihood that the products will contribute to the risk of food-borne illness;
the best available evidence concerning reported illnesses associated with the foods produced in the proposed subcategory of establishments; and
the overall record of compliance with the food safety law among establishments in the proposed subcategory, including compliance with applicable performance standards and the frequency of recalls.
The Administrator may adopt alternative inspection frequencies for increased or decreased inspection for a specific establishment, subject to paragraphs (2) and (5) and shall periodically publish a list of establishments subject to alternative inspections.
In adopting alternative inspection frequencies for a specific establishment, the Administrator shall consider—
the criteria in paragraph (3);
whether products from the specific establishment have been associated with a case or an outbreak of food-borne illness; and
the record of the establishment of compliance with the food safety law, including compliance with applicable performance standards and the frequency of recalls.
Before establishing decreased alternative inspection frequencies for subcategories of establishments or individual establishments, the Administrator shall—
determine, based on the best available evidence, that the alternative uses of the resources required to carry out the inspection activity would make a greater contribution to protecting the public health and reducing the risk of food-borne illness than the use of resources described in subsection (b);
describe the alternative uses of resources in general terms when issuing the regulation or order that establishes the alternative inspection frequency;
consider the supporting evidence that an individual food establishment shall submit related to whether an alternative inspection frequency should be established for such establishment by the Administrator; and
include a description of the alternative uses in the annual resource plan required in section 209.
The Administrator shall manage the transition to the inspection system described in this Act as follows:
In the case of a category 1 or 2 food establishment, the Administrator shall continue to implement the applicable inspection mandates of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) until—
regulations required to implement this section have been promulgated;
the performance standards required by section 204(c) have been promulgated and implemented for 1 year; and
the establishment has achieved compliance with the other applicable provisions of the food safety law.
In the case of a category 1 or 2 food establishment that, within 2 years after the promulgation of the performance standards required by section 204(c), has not achieved compliance with the food safety law, the Administrator shall—
issue an order prohibiting the establishment from operating pending a demonstration by the establishment that sufficient changes in facilities, procedures, personnel, or other aspects of the process control system have been made such that the Administrator determines that compliance with the food safety law is achieved; and
following the demonstration required in subparagraph (A), issue an order authorizing the food establishment to operate subject, at a minimum, to—
the inspection requirement applicable to the establishment under subsection (b) (1) or (2); and
such other inspection or compliance measures determined by the Administrator necessary to assure compliance with the applicable food safety law.
In the case of a category 3 food establishment, the Administrator shall continue to implement the applicable inspection mandates of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) until—
the regulations required to implement this section have been promulgated;
the first resource plan under section 209 has been submitted; and
for individual establishments, compliance with the food safety law has been demonstrated.
In the case of a category 3 food establishment that, within 1 year after the promulgation of the regulations required to implement this section, have not demonstrated compliance with the food safety law, the Administrator shall—
issue an order prohibiting the establishment from operating, pending a demonstration by the establishment that sufficient changes in facilities, procedures, personnel, or other aspects of the process control system have been made such that the Administrator determines that compliance with the food safety law is achieved; and
following the demonstration required in subparagraph (A), issue an order authorizing the establishment to operate subject, at a minimum, to—
the inspection requirement applicable to the establishment under subsection (b)(3); and
such other inspection or compliance measures determined by the Administrator necessary to assure compliance with the food safety law.
In the case of a category 4 or 5 food establishment, the inspection requirements of this Act shall be implemented as soon as possible after—
the promulgation of the regulations required to implement this section;
the publication of the first resource plan under section 209; and
the commencement of the first fiscal year in which the Administration is operating with budgetary resources that Congress has appropriated following consideration of the resource plan under section 209.
Before the completion of the transition process under paragraphs (1) through (3) of subsection (e), the Administrator shall by regulation establish an official mark that shall be affixed to a food product produced in a category 1, 2, or 3 establishment, subject to subparagraph (B).
The official mark required under subparagraph (A) shall be affixed to a food product by the Administrator if the establishment has been inspected by the Administrator in accordance with the inspection frequencies under this section and the establishment is in compliance with the food safety law.
Removal of official mark
The Administrator shall promulgate regulations that provide for the removal of the official mark under this subsection if the Administrator makes a finding that the establishment is not in compliance with the food safety law.
Category 1, 2, or 3 food establishments
In the case of products produced in a category 1, 2, or 3 food establishment—
products subject to Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as of the date of enactment of this Act shall remain subject to the requirement under those Acts that they bear the mark of inspection pending completion of the transition process under paragraphs (1) through (3) of subsection (e);
the Administrator shall publicly certify on a monthly basis that the inspection frequencies required under this Act have been achieved; and
a product from an establishment that has not been inspected in accordance with the required frequencies under this section shall not bear the official mark and shall not be shipped in interstate commerce.
Category 4 and 5 food establishments
In the case of a product produced in a category 4 or 5 food establishment the Administrator shall provide by regulation for the voluntary use of the official mark established under paragraph (1), subject to—
such minimum inspection frequencies as determined appropriate by the Administrator;
compliance with applicable performance standards and other provisions of the food safety law; and
such other requirements the Administrator considers appropriate.
Not later than 1 year after the effective date of this Act, the Administrator shall issue regulations to implement subsections (b) through (e).
Maintenance and inspection of records
A food establishment shall—
maintain such records as the Administrator shall require by regulation, including all records relating to the processing, distributing, receipt, or importation of any food; and
permit the Administrator, in addition to any authority of the food safety agencies in effect on the day before the date of enactment of this Act, upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and copy all records maintained by or on behalf of such food establishment representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator—
to determine whether the food is contaminated or not in compliance with the food safety law; or
to track the food in commerce.
A food establishment shall have an affirmative obligation to disclose to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant.
Maintenance of records
The records in paragraph (1) shall be maintained for a reasonable period of time, as determined by the Administrator.
The records in paragraph (1) shall include records describing—
the origin, receipt, delivery, sale, movement, holding, and disposition of food or ingredients;
the identity and quantity of ingredients used in the food;
the processing of the food;
the results of laboratory, sanitation, or other tests performed on the food or in the food establishment;
consumer complaints concerning the food or packaging of the food;
the production codes, open date codes, and locations of food production; and
other matters reasonably related to whether food is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act.
Protection of sensitive information
The Administrator shall develop and maintain procedures to prevent the unauthorized disclosure of any trade secret or confidential information obtained by the Administrator.
The requirement under this subsection does not—
limit the authority of the Administrator to inspect or copy records or to require the establishment or maintenance of records under this Act;
have any legal effect on section 1905 of title 18, United States Code;
extend to any food recipe, financial data, pricing data, personnel data, or sales data (other than shipment dates relating to sales);
limit the public disclosure of distribution records or other records related to food subject to a voluntary or mandatory recall under section 403; or
limit the authority of the Administrator to promulgate regulations to permit the sharing of data with other governmental authorities.
Bribery of or gifts to inspector or other officers and acceptance of gifts
Section 22 of the Federal Meat Inspection Act (21 U.S.C. 622) shall apply under this Act.
Food production facilities
In carrying out the duties of the Administrator and the purposes of this Act, the Administrator shall have the authority, with respect to food production facilities, to—
visit and inspect food production facilities in the United States and in foreign countries to investigate bioterrorism threats and for other critical food safety purposes;
review food safety records as required to be kept by the Administrator to carry out traceback and for other critical food safety purposes;
set good practice standards to protect the public and animal health and promote food safety;
conduct monitoring and surveillance of animals, plants, products, or the environment, as appropriate; and
collect and maintain information relevant to public health and farm practices.
Federal and State cooperation
The Administrator shall work with the States to carry out activities and programs that create a national food safety program so that Federal and State programs function in a coordinated and cost-effective manner.
The Administrator shall work with States to—
continue, strengthen, or establish State food safety programs, especially with respect to the regulation of retail commercial food establishments, transportation, harvesting, and fresh markets;
continue, strengthen, or establish inspection programs and requirements to ensure that food under the jurisdiction of the State is safe; and
support recall authorities at the State and local levels.
To assist in planning, developing, and implementing a food safety program, the Administrator may provide and continue to a State—
technical and laboratory assistance and training (including necessary materials and equipment); and
financial, in kind, and other aid.
The Administrator may, under agreements entered into with Federal, State, or local agencies, use on a reimbursable basis or otherwise, the personnel and services of those agencies in carrying out this Act.
Agreements with a State under this subsection may provide for training of State employees.
Maintenance of agreements
The Administrator shall maintain any agreement that is in effect on the day before the date of enactment of this Act until the Administrator evaluates such agreement and determines whether to maintain or substitute such agreement.
The Administrator shall annually conduct a comprehensive review of each State program that provides services to the Administrator in carrying out the responsibilities under this Act, including mandated inspections under section 205.
The review shall—
include a determination of the effectiveness of the State program; and
identify any changes necessary to ensure enforcement of Federal requirements under this Act.
No Federal Preemption
Nothing in this Act shall be construed to preempt the enforcement of State food safety laws and standards that are at least as stringent as those under this Act.
Not later than 2 years after the effective date of this Act, the Administrator shall establish a system under which a foreign government or foreign food establishment seeking to import food to the United States shall submit a request for certification to the Administrator.
A foreign government or foreign food establishment requesting a certification to import food to the United States shall demonstrate, in a manner determined appropriate by the Administrator, that food produced under the supervision of a foreign government or by the foreign food establishment has met standards for food safety, inspection, labeling, and consumer protection that are at least equivalent to standards applicable to food produced in the United States.
Request by foreign government
Prior to granting the certification request of a foreign government, the Administrator shall review, audit, and certify the food safety program of a requesting foreign government (including all statutes, regulations, and inspection authority) as at least equivalent to the food safety program in the United States, as demonstrated by the foreign government.
Request by foreign food establishment
Prior to granting the certification request of a foreign food establishment, the Administrator shall certify, based on an onsite inspection, the food safety programs and procedures of a requesting foreign firm as at least equivalent to the food safety programs and procedures of the United States.
A foreign government or foreign firm approved by the Administrator to import food to the United States under this section shall be certified to export only the approved food products to the United States for a period not to exceed 5 years.
Withdrawal of certification
The Administrator may withdraw certification of any food from a foreign government or foreign firm—
if such food is linked to an outbreak of human illness;
following an investigation by the Administrator that finds that the foreign government programs and procedures or foreign food establishment is no longer equivalent to the food safety programs and procedures in the United States; or
following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to fulfill the requirements under this section.
Renewal of certification
The Administrator shall audit foreign governments and foreign food establishments at least every 5 years to ensure the continued compliance with the standards set forth in this section.
Required routine inspection
The Administrator shall routinely inspect food and food animals (via a physical examination) before it enters the United States to ensure that it is—
labeled as required for food produced in the United States; and
otherwise meets requirements under the food safety law.
The Administrator is authorized to—
deny importation of food from any foreign government that does not permit United States officials to enter the foreign country to conduct such audits and inspections as may be necessary to fulfill the requirements under this section;
deny importation of food from any foreign government or foreign firm that does not consent to an investigation by the Administration when food from that foreign country or foreign firm is linked to a food-borne illness outbreak or is otherwise found to be adulterated or mislabeled; and
promulgate rules and regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the standards of this Act.
Detention and seizure
Any food imported for consumption in the United States may be detained, seized, or condemned pursuant to section 402.
The Administrator shall prepare and update annually a resource plan describing the resources required, in the best professional judgment of the Administrator, to develop and fully implement the national food safety program established under this Act.
Contents of plan
The resource plan shall—
describe quantitatively the personnel, financial, and other resources required to carry out the inspection of food establishments under section 205 and other requirements of the national food safety program;
allocate inspection resources in a manner reflecting the distribution of risk and opportunities to reduce risk across the food supply to the extent feasible based on the best available information, and subject to section 205; and
describe the personnel, facilities, equipment, and other resources needed to carry out inspection and other oversight activities, at a total resource level equal to at least 50 percent of the resources required to carry out inspections in food establishments under section 205—
in foreign establishments;
at the point of importation; and
at the point of production on farms, ranches, and feedlots.
The resource plan shall include recommendations for funding to provide grants to States and local governments to carry out food safety activities in retail and food service facilities and the required inspections in food establishments.
Submission of plan
The Administrator shall submit annually to the Committee on Appropriations of the Senate, the Committee on Appropriations of the House of Representatives, and other relevant committees of Congress, the resource plan required under this section.
The Administrator, in order to protect the public health, shall establish requirements for a national system for tracing food and food producing animals from point of origin to retail sale, subject to subsection (b).
Traceability requirements shall—
be established in accordance with regulations and guidelines issued by the Administrator; and
apply to food production facilities and food establishments.
Relationship to country of origin labeling
Nothing contained in this section prevents or interferes with implementation of the country of origin labeling requirements of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.).
Research and education
Public health assessment system
The Administrator, acting in coordination with the Director of the Centers for Disease Control and Prevention and with the Research Education and Economics mission area of the Department of Agriculture, shall—
have access to the applicable data systems of the Centers for Disease Control and Prevention and to the databases made available by a State;
maintain an active surveillance system of food, food products, and epidemiological evidence submitted by States to the Centers for Disease Control and Prevention based on a representative proportion of the population of the United States;
assess the frequency and sources of human illness in the United States associated with the consumption of food;
maintain a state-of-the-art DNA matching system and epidemiological system dedicated to food-borne illness identification, outbreaks, and containment; and
have access to the surveillance data created via monitoring and statistical studies conducted as part of its own inspection.
Public health sampling
Not later than 1 year after the effective date of this Act, the Administrator shall establish guidelines for a sampling system under which the Administrator shall take and analyze samples of food—
to assist the Administrator in carrying out this Act; and
to assess the nature, frequency of occurrence, and quantities of contaminants in food.
The sampling system described in paragraph (1) shall provide—
statistically valid monitoring, including market-based studies, on the nature, frequency of occurrence, and quantities of contaminants in food available to consumers; and
at the request of the Administrator, such other information, including analysis of monitoring and verification samples, as the Administrator determines may be useful in assessing the occurrence of contaminants in food.
Assessment of health hazards
Through the surveillance system referred to in subsection (a) and the sampling system described in subsection (b), the Administrator shall—
rank food categories based on the hazard to human health presented by the food category;
identify appropriate industry and regulatory approaches to minimize hazards in the food supply; and
assess the public health environment for emerging diseases, including zoonosis, for their risk of appearance in the United States food supply.
Components of analysis
The analysis under subsection (b)(1) may include—
a comparison of the safety of commercial processing with the health hazards associated with food that is harvested for recreational or subsistence purposes and prepared noncommercially;
a comparison of the safety of food that is domestically processed with the health hazards associated with food that is processed outside the United States;
a description of contamination originating from handling practices that occur prior to or after the sale of food to consumers; and
use of comparative risk assessments.
Public education and advisory system
The Administrator, in cooperation with private and public organizations, including the cooperative extension services and building on the efforts of appropriate State and local entities, shall establish a national public education program on food safety.
The program shall provide—
information to the public regarding Federal standards and best practices and promotion of public awareness, understanding, and acceptance of those standards and practices;
information for health professionals—
to improve diagnosis and treatment of food-related illness; and
to advise individuals at special risk for food-related illnesses; and
such other information or advice to consumers and other persons as the Administrator determines will promote the purposes of this Act.
The Administrator, in consultation with other Federal departments and agencies as the Administrator determines necessary, shall work with the States and other appropriate entities—
to develop and distribute regional and national advisories concerning food safety;
to develop standardized formats for written and broadcast advisories;
to incorporate State and local advisories into the national public education program established under subsection (a); and
to present prompt, specific information regarding foods found to pose a threat to the public health.
The Administrator shall conduct research to carry out this Act, including studies to—
improve sanitation and food safety practices in the processing of food;
develop improved techniques to monitor and inspect food;
develop efficient, rapid, and sensitive methods to detect contaminants in food;
determine the sources of contamination of contaminated food;
develop food consumption data;
identify ways that animal production techniques could improve the safety of the food supply;
draw upon research and educational programs that exist at the State and local level;
utilize the DNA matching system and other processes to identify and control pathogens;
address common and emerging zoonotic diseases;
develop methods to reduce or destroy harmful pathogens before, during, and after processing;
analyze the incidence of antibiotic resistence as it pertains to the food supply and develop new methods to reduce the transfer of antibiotic resistance to humans; and
conduct other research that supports the purposes of this Act.
The Administrator may enter into contracts and agreements with any State, university, Federal Government agency, or person to carry out this section.
It is prohibited—
to manufacture, introduce, deliver for introduction, or receive into interstate commerce any food that is adulterated, misbranded, or otherwise unsafe;
to adulterate or misbrand any food in interstate commerce;
for a food establishment or foreign food establishment to fail to register under section 202, or to operate without a valid registration;
to refuse to permit access to a food establishment for the inspection and copying of a record as required under section 205(h);
to fail to establish or maintain any record or to make any report as required under section 205(h);
to refuse to permit entry to or inspection of a food establishment as required under section 205;
to fail to provide to the Administrator the results of a testing or sampling of a food, equipment, or material in contact with contaminated food under section 205(i);
to fail to comply with a provision, regulation, or order of the Administrator under section 202, 203, 204, or 208;
to slaughter an animal that is capable for use in whole or in part as human food at a food establishment processing any such food for commerce, except in compliance with the food safety law;
to transfer food in violation of an administrative detention order under section 402 or to remove or alter a required mark or label identifying the food as detained;
to fail to comply with a recall or other order under section 403; or
to otherwise violate the food safety law.
Food detention, seizure, and condemnation
Administrative detention of food
The Administrator shall have authority under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) to administratively detain and seize any food that the Administrator has reason to believe is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of the food safety law.
If, during an inspection conducted in accordance with section 205 or 208, an officer, employee, or agent of the Administration making the inspection has reason to believe that a domestic food, imported food, or food offered for import is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act, the officer or employee may order the food detained.
Period of detention
A food may be detained for a reasonable period, not to exceed 20 days, unless a longer period, not to exceed 30 days, is necessary for the Administrator to institute a seizure action.
The Administrator shall provide by regulation for procedures to institute a seizure action on an expedited basis with respect to perishable food.
Security of detained food
A detention order—
may require that the food be labeled or marked as detained; and
shall require that the food be removed to a secure facility, if appropriate.
Food subject to an order
A food subject to a detention order shall not be transferred by any person from the place at which the food is removed, until released by the Administrator or until the expiration of the detention period applicable under the order, whichever occurs first.
Delivery of food
This subsection does not authorize the delivery of a food in accordance with execution of a bond while the article is subject to the order.
Appeal of detention order
A person who would be entitled to be a claimant for a food subject to a detention order if the food were seized under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334), may appeal the order to the Administrator.
Action by the administrator
Not later than 5 days after an appeal is filed under paragraph (1), the Administrator, after providing an opportunity for an informal hearing, shall confirm, modify, or terminate the order involved.
Final agency action
Confirmation, modification, or termination by the Administrator under paragraph (2) shall be considered a final agency action for purposes of section 702 of title 5, United States Code.
The order shall be considered to be terminated if, after 5 days, the Administrator has failed—
to provide an opportunity for an informal hearing; or
to confirm, modify, or terminate the order.
Effect of instituting court action
If the Administrator initiates an action under section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) or section 304(a) of that Act (21 U.S.C. 334(a)), the process for the appeal of the detention order shall terminate.
Condemnation of food
After confirming a detention order, the Administrator may order the food condemned.
Destruction of food
Any food condemned shall be destroyed under the supervision of the Administrator.
Release of food
If the Administrator determines that, through reprocessing, relabeling, or other action, a detained food can be brought into compliance with this Act, the food may be released following a determination by the Administrator that the relabeling or other action as specified by the Administrator has been performed.
Temporary holds at ports of entry
If an officer or qualified employee of the Administration has reason to believe that a food is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act, and the officer or qualified employee is unable to inspect, examine, or investigate the food when the food is offered for import at a port of entry into the United States, the officer or qualified employee shall request the Secretary of Homeland Security to hold the food at the port of entry for a reasonable period of time, not to exceed 24 hours, to enable the Administrator to inspect or investigate the food as appropriate.
Removal to secure facility
The Administrator shall work in coordination with the Secretary of Homeland Security to remove a food held in accordance with paragraph (1) to a secure facility as appropriate.
Prohibition on transfer
During the period in which the food is held, the food shall not be transferred by any person from the port of entry into the United States, or from the secure facility to which the food has been removed.
Delivery in accordance with a bond
The delivery of the food in accordance with the execution of a bond while the food is held is not authorized.
Prohibition on Reexport
A food found unfit for human or animal consumption shall be prohibited from reexport without further processing to remove the contamination and reinspection by the Administration.
Notification and recall
Notice to Administrator of violation
A person that has reason to believe that any food introduced into or in interstate commerce, or held for sale (whether or not the first sale) after shipment in interstate commerce, may be in violation of the food safety law shall immediately notify the Administrator of the identity and location of the food.
Manner of notification
Notification under paragraph (1) shall be made in such manner and by such means as the Administrator may require by regulation.
Recall and consumer notification
If the Administrator determines that food is in violation of the food safety law when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce and that there is a reasonable probability that the food, if consumed, would present a threat to public health, as determined by the Administrator, the Administrator shall give the appropriate persons (including the manufacturers, importers, distributors, or retailers of the food) an opportunity to—
cease distribution of the food;
notify all persons—
processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or
to which the food has been distributed, transported, or sold, to immediately cease distribution of the food;
recall the food;
in conjunction with the Administrator, provide notice of the finding of the Administrator—
to consumers to whom the food was, or may have been, distributed; and
to State and local public health officials; or
take any combination of the measures described in this paragraph, as determined by the Administrator to be appropriate in the circumstances.
If a person referred to in paragraph (1) refuses to or does not adequately carry out the actions described in that paragraph within the time period and in the manner prescribed by the Administrator, the Administrator shall—
have authority to control and possess the food, including ordering the shipment of the food from the food establishment to the Administrator—
at the expense of the food establishment; or
in an emergency (as determined by the Administrator), at the expense of the Administration; and
by order, require, as the Administrator determines to be necessary, the person to immediately—
cease distribution of the food; and
notify all persons—
processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or
if the food has been distributed, transported, or sold, to immediately cease distribution of the food.
Notification to consumers by administrator
The Administrator shall, as the Administrator determines to be necessary, provide notice of the finding of the Administrator under paragraph (1)—
to consumers to whom the food was, or may have been, distributed; and
to State and local public health officials.
Nondistribution by notified persons
A person that processes, distributes, or otherwise handles the food, or to which the food has been distributed, transported, or sold, and that is notified under paragraph (1)(B) or (2)(B) shall immediately cease distribution of the food.
Availability of records to administrator
Each person referred to in paragraph (1) that processed, distributed, or otherwise handled food shall make available to the Administrator information necessary to carry out this subsection, as determined by the Administrator, regarding—
persons that processed, distributed, or otherwise handled the food; and
persons to which the food has been transported, sold, distributed, or otherwise handled.
Informal hearings on orders
The Administrator shall provide any person subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as practicable but not later than 2 business days after the issuance of the order.
Scope of the hearing
In a hearing under paragraph (1), the Administrator shall consider the actions required by the order and any reasons why the food that is the subject of the order should not be recalled.
Post-Hearing recall orders
Amendment of order
If, after providing an opportunity for an informal hearing under subsection (c), the Administrator determines that there is a reasonable probability that the food that is the subject of an order under subsection (b), if consumed, would present a threat to the public health, the Administrator, as the Administrator determines to be necessary, may—
amend the order to require recall of the food or other appropriate action;
specify a timetable in which the recall shall occur;
require periodic reports to the Administrator describing the progress of the recall; and
provide notice of the recall to consumers to whom the food was, or may have been, distributed.
Vacation of orders
If, after providing an opportunity for an informal hearing under subsection (c), the Administrator determines that adequate grounds do not exist to continue the actions required by the order, the Administrator shall vacate the order.
Remedies not exclusive
The remedies provided in this section shall be in addition to, and not exclusive of, other remedies that may be available.
The district courts of the United States, and the United States courts of the territories and possessions of the United States, shall have jurisdiction, for cause shown, to restrain a violation of section 202, 203, 204, 207, or 401 (or a regulation promulgated under that section).
In a case in which violation of an injunction or restraining order issued under this section also constitutes a violation of the food safety law, trial shall be by the court or, upon demand of the accused, by a jury.
Civil and criminal penalties
Any person that commits an act that violates the food safety law (including a regulation promulgated or order issued under a Federal food safety law) may be assessed a civil penalty by the Administrator of not more than $10,000 for each such act.
Each act described in subparagraph (A) and each day during which that act continues shall be considered a separate offense.
The civil penalty described in paragraph (1) shall be assessed by the Administrator by a written order, which shall specify the amount of the penalty and the basis for the penalty under subparagraph (B) considered by the Administrator.
Amount of penalty
Subject to paragraph (1)(A), the amount of the civil penalty shall be determined by the Administrator, after considering—
the gravity of the violation;
the degree of culpability of the person;
the size and type of the business of the person; and
any history of prior offenses by the person under the food safety law.
Review of order
The order may be reviewed only in accordance with subsection (c).
Except as provided in paragraphs (2) and (3), a person that knowingly produces or introduces into commerce food that is unsafe or otherwise adulterated or misbranded shall be imprisoned for not more than 1 year or fined not more than $10,000, or both.
A person that commits a violation described in paragraph (1) after a conviction of that person under this section has become final, or commits such a violation with the intent to defraud or mislead, shall be imprisoned for not more than 3 years or fined not more than $100,000, or both.
No person shall be subject to the penalties of this subsection—
for having received, proffered, or delivered in interstate commerce any food, if the receipt, proffer, or delivery was made in good faith, unless that person refuses to furnish (on request of an officer or employee designated by the Administrator)—
the name, address and contact information of the person from whom that person purchased or received the food;
copies of all documents relating to the person from whom that person purchased or received the food; and
copies of all documents pertaining to the delivery of the food to that person; or
if that person establishes a guaranty signed by, and containing the name and address of, the person from whom that person received in good faith the food, stating that the food is not adulterated or misbranded within the meaning of this Act.
An order assessing a civil penalty under subsection (a) shall be a final order unless the person—
not later than 30 days after the effective date of the order, files a petition for judicial review of the order in the United States court of appeals for the circuit in which that person resides or has its principal place of business or the United States Court of Appeals for the District of Columbia; and
simultaneously serves a copy of the petition by certified mail to the Administrator.
Filing of record
Not later than 45 days after the service of a copy of the petition under paragraph (1)(B), the Administrator shall file in the court a certified copy of the administrative record upon which the order was issued.
Standard of review
The findings of the Administrator relating to the order shall be set aside only if found to be unsupported by substantial evidence on the record as a whole.
Collection actions for failure To pay
If any person fails to pay a civil penalty assessed under subsection (a) after the order assessing the penalty has become a final order, or after the court of appeals described in subsection (b) has entered final judgment in favor of the Administrator, the Administrator shall refer the matter to the Attorney General, who shall institute in a United States district court of competent jurisdiction a civil action to recover the amount assessed.
Limitation on review
In a civil action under paragraph (1), the validity and appropriateness of the order of the Administrator assessing the civil penalty shall not be subject to judicial review.
Penalties paid into account
shall deposit penalties collected under this section in an account in the Treasury; and
may use the funds in the account, without further appropriation or fiscal year limitation—
to carry out enforcement activities under food safety law; or
to provide assistance to States to inspect retail commercial food establishments or other food or firms under the jurisdiction of State food safety programs.
Discretion of the Administrator to prosecute
Nothing in this Act requires the Administrator to report for prosecution, or for the commencement of an action, the violation of the food safety law in a case in which the Administrator finds that the public interest will be adequately served by the assessment of a civil penalty under this section.
Remedies not exclusive
The remedies provided in this section may be in addition to, and not exclusive of, other remedies that may be available.
In any action to enforce the requirements of the food safety law, the connection with interstate commerce required for jurisdiction shall be presumed to exist.
No Federal employee, employee of a Federal contractor or
subcontractor, or any individual employed by a company (referred to in this
section as a
covered individual), may be discharged, demoted,
suspended, threatened, harassed, or in any other manner discriminated against,
because of any lawful act done by the covered individual to—
provide information, cause information to be provided, or otherwise assist in an investigation regarding any conduct that the covered individual reasonably believes constitutes a violation of any law, rule, or regulation, or that the covered individual reasonably believes constitutes a threat to the public health, when the information or assistance is provided to, or the investigation is conducted by—
a Federal regulatory or law enforcement agency;
a Member or committee of Congress; or
a person with supervisory authority over the covered individual (or such other individual who has the authority to investigate, discover, or terminate misconduct);
file, cause to be filed, testify, participate in, or otherwise assist in a proceeding or action filed or about to be filed relating to a violation of any law, rule, or regulation; or
refused to violate or assist in the violation of any law, rule, or regulation.
A covered individual who alleges discharge or other discrimination by any person in violation of subsection (a) may seek relief under subsection (c) by filing a complaint with the Secretary of Labor. If the Secretary of Labor has not issued a final decision within 180 days after the date on which the complaint is filed and there is no showing that such delay is due to the bad faith of the claimant, the claimant may bring an action at law or equity for de novo review in the appropriate district court of the United States, which shall have jurisdiction over such an action without regard to the amount in controversy.
An action under paragraph (1) shall be governed under the rules and procedures set forth in section 42121(b) of title 49, United States Code.
Notification under section 42121(b)(1) of title 49, United States Code, shall be made to the person named in the complaint and to the person’s employer.
Burdens of proof
An action brought under paragraph (1) shall be governed by the legal burdens of proof set for in section 42121(b) of title 49, United States Code.
Statute of limitations
An action under paragraph (1) shall be commenced not later than 90 days after the date on which the violation occurs.
A covered individual prevailing in any action under subsection (b)(1) shall be entitled to all relief necessary to make the covered individual whole.
Relief for any action described in paragraph (1) shall include—
reinstatement with the same seniority status that the covered individual would have had, but for the discrimination;
the amount of any back pay, with interest; and
compensation for any special damages sustained as a result of the discrimination, including litigation costs, expert witness fees, and reasonable attorney’s fees.
Rights retained by the covered individual
Nothing in this section shall be construed to diminish the rights, privileges, or remedies of any covered individual under any Federal or State law, or under any collective bargaining agreement.
Administration and enforcement
For the efficient administration and enforcement of the food safety law, the provisions (including provisions relating to penalties) of sections 6, 8, 9, and 10 of the Federal Trade Commission Act (15 U.S.C. 46, 48, 49, and 50) (except subsections (c) through (h) of section 6 of that Act), relating to the jurisdiction, powers, and duties of the Federal Trade Commission and the Attorney General to administer and enforce that Act, and to the rights and duties of persons with respect to whom the powers are exercised, shall apply to the jurisdiction, powers, and duties of the Administrator and the Attorney General in administering and enforcing the provisions of the food safety law and to the rights and duties of persons with respect to whom the powers are exercised, respectively.
Inquiries and actions
The Administrator, in person or by such agents as the Administrator may designate, may prosecute any inquiry necessary to carry out the duties of the Administrator under the food safety law in any part of the United States.
The powers conferred by sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49 and 50) on the United States district courts may be exercised for the purposes of this chapter by any United States district court of competent jurisdiction.
Citizen civil actions
A person may commence a civil action against—
a person that violates a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator to ensure the safety of food; or
the Administrator (in his or her capacity as the Administrator), if the Administrator fails to perform an act or duty to ensure the safety of food that is not discretionary under the food safety law.
The action shall be commenced in the United States district court for the district in which the defendant resides, is found, or has an agent.
The court shall have jurisdiction, without regard to the amount in controversy, or the citizenship of the parties, to enforce a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator, or to order the Administrator to perform the act or duty.
The court may—
award damages, in the amount of damages actually sustained; and
if the court determines it to be in the interest of justice, award the plaintiff the costs of suit, including reasonable attorney’s fees, reasonable expert witness fees, and penalties.
Remedies not exclusive
The remedies provided for in this section shall be in addition to, and not exclusive of, other remedies that may be available.
For purposes of this title, the term transition period means the 12-month period beginning on the effective date of this Act.
Submission of plan
Not later than 180 days after the effective date of this Act, the President shall transmit to the appropriate congressional committees a reorganization plan regarding the following:
The transfer of agencies, personnel, assets, and obligations to the Administration pursuant to this Act.
Any consolidation, reorganization, or streamlining of agencies transferred to the Administration pursuant to this Act.
The plan transmitted under subsection (a) shall contain, consistent with this Act, such elements as the President determines appropriate, including the following:
Identification of any functions of agencies designated to be transferred to the Administration pursuant to this Act that will not be transferred to the Administration under the plan.
Specification of the steps to be taken by the Administrator to organize the Administration, including the delegation or assignment of functions transferred to the Administration among the officers of the Administration in order to permit the Administration to carry out the functions transferred under the plan.
Specification of the funds available to each agency that will be transferred to the Administration as a result of transfers under the plan.
Specification of the proposed allocations within the Administration of unexpended funds transferred in connection with transfers under the plan.
Specification of any proposed disposition of property, facilities, contracts, records, and other assets and obligations of agencies transferred under the plan.
Specification of the proposed allocations within the Administration of the functions of the agencies and subdivisions that are not related directly to ensuring the safety of food.
Modification of plan
The President may, on the basis of consultations with the appropriate congressional committees, modify, or revise any part of the plan until that part of the plan becomes effective in accordance with subsection (d).
The reorganization plan described in this section, including any modifications or revisions of the plan under subsection (c), shall become effective for an agency on the earlier of—
the date specified in the plan (or the plan as modified pursuant to subsection (c)), except that such date may not be earlier than 90 days after the date the President has transmitted the reorganization plan to the appropriate congressional committees pursuant to subsection (a); or
the end of the transition period.
Nothing in this subsection may be construed to require the transfer of functions, personnel, records, balances of appropriations, or other assets of an agency on a single date.
Supercedes existing law
Paragraph (1) shall apply notwithstanding section 905(b) of title 5, United States Code.
Provision of assistance by officials
Until the transfer of an agency to the Administration, any official having authority over or function relating to the agency immediately before the effective date of this Act shall provide the Administrator such assistance, including the use of personnel and assets, as the Administrator may request in preparing for the transfer and integration of the agency to the Administration.
Services and personnel
During the transition period, upon the request of the Administrator, the head of any executive agency may, on a reimbursable basis, provide services or detail personnel to assist with the transition.
During the transition period, pending the advice and consent of the Senate to the appointment of an officer required by this Act to be appointed by and with such advice and consent, the President may designate any officer whose appointment was required to be made by and with such advice and consent and who was such an officer immediately before the effective date of this Act (and who continues to be in office) or immediately before such designation, to act in such office until the same is filled as provided in this Act.
While acting pursuant to paragraph (1), such officers shall receive compensation at the higher of—
the rates provided by this Act for the respective offices in which they act; or
the rates provided for the offices held at the time of designation.
Nothing in this Act shall be construed to require the advice and consent of the Senate to the appointment by the President to a position in the Administration of any officer whose agency is transferred to the Administration pursuant to this Act and whose duties following such transfer are germane to those performed before such transfer.
Transfer of personnel, assets, obligations, and function
Consistent with section 1531 of title 31, United States Code, the personnel, assets, liabilities, contracts, property, records, and unexpended balances of appropriations, authorizations, allocations, and other funds that relate to the functions transferred under subsection (a) from a Federal agency shall be transferred to the Administration.
Unexpended funds transferred under this subsection shall be used by the Administration only for the purposes for which the funds were originally authorized and appropriated.
Completed administrative actions
The enactment of this Act or the transfer of functions under this Act shall not affect any order, determination, rule, regulation, permit, personnel action, agreement, grant, contract, certificate, license, registration, privilege, or other administrative action issued, made, granted, or otherwise in effect or final with respect to that agency on the day before the transfer date with respect to the transferred functions
Subject to the authority of the Administrator under this Act—
pending proceedings in an agency, including notices of proposed rulemaking, and applications for licenses, permits, certificates, grants, and financial assistance, shall continue notwithstanding the enactment of this Act or the transfer of the agency to the Administration, unless discontinued or modified under the same terms and conditions and to the same extent that such discontinuance could have occurred if such enactment or transfer had not occurred; and
orders issued in such proceedings, and appeals therefrom, and payments made pursuant to such orders, shall issue in the same manner on the same terms as if this Act had not been enacted or the agency had not been transferred, and any such order shall continue in effect until amended, modified, superceded, terminated, set aside, or revoked by an officer of the United States or a court of competent jurisdiction, or by operation of law.
Pending civil actions
Subject to the authority of the Administrator under this Act, any civil action commenced with regard to that agency pending before that agency on the day before the transfer date with respect to the transferred functions shall continue notwithstanding the enactment of this Act or the transfer of an agency to the Administration.
After the transfer of functions from a Federal agency under this Act, any reference in any other Federal law, Executive order, rule, regulation, directive, document, or other material to that Federal agency or the head of that agency in connection with the administration or enforcement of the food safety laws shall be deemed to be a reference to the Administration or the Administrator, respectively.
Statutory reporting requirements
Statutory reporting requirements that applied in relation to such an agency immediately before the effective date of this Act shall continue to apply following such transfer if they refer to the agency by name.
Section 5313 of title 5, United States Code, is amended by inserting at the end the following new item:
Administrator of Food Safety.
Repeal of certain provisions
Section 18 of the Poultry Products Inspection Act (21 U.S.C. 467), section 401 of the Federal Meat Inspection Act (21 U.S.C. 671), and section 18 of the Egg Products Inspection Act (21 U.S.C. 1047) are repealed.
Additional technical and conforming amendments
Not later than 60 days after the submission of the reorganization plan under section 502, the President shall prepare and submit proposed legislation to Congress containing necessary and appropriate technical and conforming amendments to the Acts listed in section 3(15) of this Act to reflect the changes made by this Act.
The Administrator may promulgate such regulations as the Administrator determines are necessary or appropriate to perform the duties of the Administrator.
Authorization of appropriations
There are authorized to be appropriated such sums as are necessary to carry out this Act.
Limitation on authorization of appropriations
For the fiscal year that includes the effective date of this Act, the amount authorized to be appropriated to carry out this Act shall not exceed—
the amount appropriated for that fiscal year for the Federal agencies identified in section 102(b) for the purpose of administering or enforcing the food safety law; or
the amount appropriated for those agencies for that purpose for the preceding fiscal year, if, as of the effective date of this Act, appropriations for those agencies for the fiscal year that includes the effective date have not yet been made.
This Act takes effect on the date of enactment of this Act.